Kornimate/medical-research-clean huggingface dataset:
fluid resuscitation in patients suffering from burns injury

Conditions: Burns

Summary: this clinical study compares two fluid resuscitation treatments in patients suffering from burns injury. the treatments are volulyte® and human serum albumin (hsa) which will be administered as infusion solutions. it will be evaluated whether volulyte® is effective and safe, and provides any benefit.

severe burns injury presents a unique resuscitation problem due to simultaneous loss of electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and protein from the circulation into the interstitial compartment. in the post shock phase of burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a positive fluid balance of many litres. this pilot study will compare two burns fluid resuscitation regimes (supplementation with 6% hes 130/0.4 in an isotonic electrolyte solution, volulyte 6%, versus supplementation with human serum albumin, hsa 50g/l) on patient outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable).

Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years of age * 15%≥ burn total body surface area injury ≤60% * signed written informed consent from patient or legal representative exclusion criteria: * patient age \>80 years * delay of patient randomisation \>8 hours post-burn * known pregnancy * known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment) * high voltage electrical conduction injury * known severe liver disease * known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure * intracranial bleeding (known active or suspicion of intracranial bleeding)
aonda therapeutic indication study i

Conditions: Bullous Keratopathy; Corneal Erosion; Entropion; Corneal Edema; Corneal Dystrophy; Corneal Ulcer; Foreign Body in Cornea; Bell Palsy; Keratoconjunctivitis; Filamentary Keratitis; Sicca Syndrome; Keratoconjunctivitis (Etiology)

Summary: this study will be used to support assessment of air optix® night \& day® aqua (aonda) soft contact lenses' safety and performance in accordance with updated european union medical device regulation (eu mdr) requirements.

in this retrospective observational study, the subject wore aonda as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Eligibility criteria:
key inclusion criteria: * diagnosis of a corneal condition with pain for which aonda soft contact lens as a therapeutic contact lens was placed on one or both eye(s) at baseline. * baseline and follow-up (up to 1 year from baseline) charts available. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the investigator. * used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the investigator. * other protocol-defined exclusion criteria may apply.
switch from oral iron to intravenous ferric carboxymaltose in non-dialysis chronic kidney disease (ckd)

Conditions: Iron Deficiency; Anaemia

Summary: investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (esa) and improve hb levels and iron status in adult patients with non-dialysis-dependent ckd who were on a stable esa/oral iron schedule for 6 months prior to enrolment.


Eligibility criteria:
inclusion criteria: * \>18 years of age * creatinine clearance ≤40 ml/min * hemoglobin 110-120 g/l * serum ferritin \<100 µg/l or transferrin saturation \<20% * monthly treatment with esa and oral iron for at least six months before enrolment exclusion criteria: * other obvious cause of acute or chronic anemia than iron deficiency * expectation to require hemodialysis within the next six months * short life expectancy (\<1 year) * pregnancy * decompensated heart failure * history of allergic reactions to iron preparations and/or anaphylaxis from any cause * requirement of blood transfusions * chronic decompensated mental disorder or dementia

Keywords: chronic kidney disease ckd non-dialysis-dependent nd-ckd erythropoiesis-stimulating agent ferric carboxymaltose iron
protocol-based management and perioperative outcomes in patients with chronic antithrombotic therapy

Conditions: Antithrombotic Therapy; Perioperative Care; Perioperative Outcomes

Summary: the purpose of this pragmatic interventional study is to evaluate whether a protocol-based management of antithrombotic drugs can reduce a composite of perioperative outcomes in patients with chronic antithrombotic therapy before surgery.

aging population and chronic medical disease make the management of surgical patients more complex. about one tenth of patients scheduled for surgery are taking antithrombotic medications. coagulation disturbance induced by these medications may increase the risk of bleeding, whereas withholding these medications may increase the risk of thrombotic events. it is a dilemma when managing these patients. the guidelines and expert consensus published by multiple disciplinary teams constitute the perioperative antithrombotic management protocols. however, the effects of perioperative antithrombotic management guided by these guidelines or expert consensus are seldom reported. the investigators hypothesize that a protocol-based perioperative antithrombotic management can benefit patients with chronic antithrombotic therapy before surgery.

Eligibility criteria:
inclusion criteria: * 1. patients with continuing antithrombotic therapy (including antiplatelet and/or anticoagulant therapies) for cardiovascular and cerebrovascular diseases for more than 2 weeks. * 2. patients who have one or more of the following situations: (1) non-valvular atrial fibrillation with a cha2ds2-vasc score \>4; (2) post-artificial valve replacement (including mitral valve, ball-cage valve or tilting disc aortic valve); (3) venous thromboembolism occurred within 1 year, or venous thromboembolism with other high-risk factors which require long-term anticoagulation treatment; (4) coronary heart disease with coronary stent implantation, thrombolytic therapy or other coronary procedures within 2 years, or who had undergone coronary artery bypass grafting within 1 year, or who experienced myocardial infarction or acute coronary syndrome within 1 year; (5) a history of stroke/transient ischemic accident within 1 year, or a history of cervical or intracranial revascularization treatment within 1 year; (6) peripheral arterial disease. * 3. patients who are scheduled to undergo intra-abdominal surgery (including general and urologic surgery). * 4. patients who sign written informed consents. exclusion criteria: * 1. refuse to participate. * 2. emergency surgery. * 3. unable to complete the preoperative assessment and follow-up plan. * 4. other reasons that are considered unsuitable for study participation by the investigators or the attending doctors.

Keywords: perioperative care antithrombotic therapy perioperative outcomes
hpv-e6-specific anti-pd1 tcr-t cells in the treatment of hpv-positive nhscc or cervical cancer

Conditions: Cervical Cancer; Head and Neck Squamous Cell Carcinoma

Summary: human papillomavirus infections 16 (hpv16) is known to be a high-risk factor to induce cervical cancers. to date, hpv16-related cervical cancer is still a major concern in developing countries where vaccination is not prevalent. concurrent therapies for cervical cancers have limited response rate and high chance of relapse. however, hpv16-induced cancers provided an ideal target for t cell-based immunotherapy due to the non-self origins. engineered t cells bearing a tcr (tcr-t) that can specifically recognize the presented hpv antigen become a viable approach to treat this type of cancer. though engineered t therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. one key mechanism of tumor-elicited suppression is the pdl1-pd1 interaction which induces t cell exhaustion. therefore, tcr-t cells armed with a pd1 antagonist could further enhance the efficacy of tcr-t in solid cancers.


Eligibility criteria:
inclusion criteria: * expected to live longer than 12 weeks * ps 0-2 * pathology confirmed as hpv16 positive malignant tumor, either metastatic or recurrent disease * creatinine \<2.5mg/dl * alt/ast is lower than three times uln. * no contraindications of leukocyte collection * before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion. * understand this trial and have signed an informed consent exclusion criteria: * patients with symptomatic brain metastasis * with other uncontrolled malignant tumors. * hepatitis b or hepatitis c activity period, hiv infected patients * any other uncontrolled disease that interferes with the trial * patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage * untreated hypertension or hypertensive patients * a person with a history of mental illness that is difficult to control * researchers do not consider it appropriate to participate in this trial * patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids * subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment * an illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements
effect of lateral positioning on bronchial cuff pressure of left-sided double-lumen endotracheal tube during thoracic surgery

Conditions: Lung Cancer; Pneumothorax

Summary: the investigators evaluate the effect of postural change on the bronchial cuff pressure (bcp) of double-lumen endotracheal tube (dlt) in patients undergoing thoracic surgery, by observing the pressure of the bronchial cuff before and after lateral decubitus positioning.

it is essential to maintain proper cuff pressure in the endotracheal tube (ett) when placing the ett in the trachea in patients undergoing general anesthesia. most of the literature recommend maintaining a pressure of 20-30 cmh2o to prevent cuff-related complications such as micro-aspiration or airway trauma. proper pressure is also important for dlts used in thoracic surgery. furthermore, the cuff pressure of the ett can change during the patient's positional changes. all things considered, we hypothesized that the change from supine to lateral decubitus position, which is essential for thoracic surgery would affect the bcp of the dlt.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status 1 or 2 2. elective lung surgery requiring lateral decubitus positioning and one-lung ventilation using left-sided dlt exclusion criteria: 1. patients requiring a right-sided dlt. 2. patients with an intraluminal lesion in the left mainstem bronchus (lmb). 3. patients with an anatomical problem in the tracheobronchial tree. 4. patients with impaired lung such as chronic obstructive pulmonary disease. 5. patients who refused to participate in this study.

Keywords: double-lumen endotracheal tube cuff pressure
topography guided lasik by different protocols for treatment of astigmatism

Conditions: Refractive Surgery

Summary: background and rationale: lasik has been among the highest satisfaction rates of surgical procedures, ranging from 82%-98%. different ablation profiles have been developed over the years. the purpose of this study is to validate this novel measurement by comparing the visual outcomes when the tmr is used in myopic astigmatic lasik to using the standard manifest refraction or the topolyzer measurements alone. objectives : to evaluate the safety, efficacy and predictability of topography-guided myopic lasik with three different refraction treatment strategies.

candidates for refractive surgery above 18 years with myopic astigmatism and no previous ocular surgery. sample size 60 eyes. surgery: * 60 eyes of myopic topography-guided lasik procedures with the same refractive platform (fs200 femtosecond to create a flap between90: 110 μm with diameter 8:9 mm and ex500 excimer lasers) will be randomized for treatment as follows: * group a: 20 eyes will be treated using contoura vision with the standard manifest refraction. * group b: 20 eyes will be treated with contoura vision using the topographic astigmatic power and axis and without change in the spherical power (using the same spherical power as the manifest refraction). * group c \[tmr\]: 20 eyes will be treated with contoura vision using the topographic astigmatic power and axis and modifying the spherical power to obtain the same spherical equivalent as the manifest refraction. this is done by subtracting half of the difference between topographic astigmatic power and the manifest astigmatic power from the spherical power (topography-modified treatment refraction). * the standard postoperative treatment is combined steroids and antibiotics eye drops 5 times daily for one week ,then three times daily for three days and lubricant eye drops 5 times daily for six months. postoperatively, the patients will be examined at 1 week, 1 month and 3 months. all postoperative follow-up visits included measurement of udva, cdva (if indicated) and refraction, besides full ophthalmological examination and performing pentacam and topolyzer after 3 months

Eligibility criteria:
inclusion criteria: * stable refractive error: myopic astigmatism ≥ -1.5 d * valid topolyzer maps (at least four out of eight right maps with green analyzed area and the registration box is green). exclusion criteria: 1. estimated postoperative residual stromal bed thickness of less than 300µm. 2. glaucomatous patients. 3. patients with keratoconus. 4. patients with pervious refractive surgery. 5. history of previous ocular trauma or surgery. 6. history of recent herpetic ulcer or viral keratitis. 7. basement membrane disease, history of recurrent corneal erosions. 8. sicca syndrome, dry eye.

Keywords: topography guided ablation astigmatism lasik
radiographic findings and clinical outcomes after bone grafting patellar defect in acl reconstruction

Conditions: Bone Graft; Complications; ACL Injuries

Summary: all patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. patients will not be advised which group they belong to until after the completion of the study. one group will be treated with autologous bone graft for bone patellar-tendon bone (btb) anterior cruciate ligament reconstruction (aclr), and the other group will be treated with commercially available dbm (demineralized bone matrix) putty. patients will be enrolled from banner university. before and after surgery, patient reported outcomes including visual analog pain scale (vas), tegner-lysholm and cincinnati acl test. the principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.


Eligibility criteria:
inclusion criteria: * 18-40 years old, * male/female/gender neutral, * all races not including vulnerable/special consideration populations, * candidate for anterior cruciate ligament reconstruction with bone patellar bone autograft, * compliant post operative course. exclusion criteria: * \ 41 years of age, * prior bone patellar bone anterior cruciate ligament reconstruction, * non-compliance post-operatively, * nicotine dependence.
dose reducing door-to-balloon time in st-elevation myocardial infarction cause less cost?

Conditions: Acute STEMI; Primary Percutaneous Coronary Arterial Intervention

Summary: the investigators tried to determined whether the less d2b time led to costs savings benefited insurance payer and better outcomes to patients.

the relationship between the quality of care and costs has been discussed widely. higher costs of care did not bring better outcomes, vice versa. however, as the rising spending of health care, the health care providers, insurance payers, governments, and consumers begin to pursue the higher quality of cares with lowest costs. in surgical experiences, improving the process of care succeeded to improve the quality of care and reduce the costs. in patients with acute st-segment elevation myocardial infarction (stemi), a door-to-balloon (d2b) time of less than 90 minutes has been established as the gold standard for primary percutaneous coronary intervention (pci) and was associated with lower in-hospital mortality.9 only less literatures discussed the costs and the quality of care in acute stemi, and whether improving processes of care associated with lower costs was still controversial. the premier hospital quality incentive demonstration (phqid) in united state improved the processes of care but had not a significant effect on cost. another single hospital experience in indiana, usa, showed that the reducing d2b time in stemi decreased the insurance payments as well as the total hospital costs. however, this study design was before-and-after intervention analysis, did not actually measure the impact of d2b time. besides, the payment system in this study was prospective payment, not fee-for-service payment in taiwan. in this study, we tried to determined whether the less d2b time led to costs savings benefited insurance payer and better outcomes to patients.

Eligibility criteria:
inclusion criteria: * self visit * acute stemi by ecg definition exclusion criteria: * non-diagnosis on first ecg * transferred * diagnostic angiogram only
evaluating the reach of clinical decision support for patients with heart failure

Conditions: Decision Support Systems, Clinical; Heart Failure

Summary: to work best, clinical decision support tools (cds) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). unfortunately, most cds tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. the objective of this study is to test the reach, feasibility and acceptability of a new cds tool for heart failure with reduced ejection fraction (hfref) during virtual visits. this new cds tool was developed through an iterative design process, and will be compared to an existing hfref cds tool in a randomized pilot study at outpatient cardiology clinics throughout the uchealth system.


Eligibility criteria:
inclusion criteria: * the study subjects are potential users of the cds, specifically clinicians with prescribing privileges who practice at one of the health system's (uchealth) outpatient cardiology clinics. because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions. exclusion criteria: * clinicians who do not practice in a uchealth cardiology clinic.
test efficacy of biodegradable and permanent limus-eluting stents

Conditions: Coronary Heart Disease

Summary: the aim of this prospective, randomized study is to compare the efficacy and safety of biodegradable polymer based limus-eluting stents (bpdes) with permanent polymer based everolimus eluting stents (ppdes).

restenosis affects 20-40% of de novo coronary lesions treated with bare-metal stents. although it is often considered a benign process, recent data indicate that in-stent restenosis has a negative impact on long-term survival of patients treated with coronary stents. drug eluting stents have emerged as the most effective strategy for the prevention of restenosis. a large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare-metal stents. available evidence shows that all 3 limus drugs - rapamycin, everolimus and biolimus - are very effective in suppressing neointima formation after coronary stenting. drugs are fully released within a few weeks from the majority of current des. however, most of the des use permanent polymers, which continue to remain in the vessel wall even after accomplishing their drug-release mission. their permanent presence may be associated with persistent inflammatory reaction and delayed neointimal proliferation and vessel thrombosis. clinical trial evidence with biodegradable polymer des is still limited, but there are great expectations that this des technology might be the dominant one in the years to come.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels. * written, informed consent by the patient or her/his legally-authorized representative for participation in the study. * in women with childbearing potential a negative pregnancy test is mandatory. exclusion criteria: * target lesion located in the left main trunk. * in-stent restenosis of des. * cardiogenic shock. * malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. * known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome. * inability to take dual antiplatelet therapy for at least 6 months. * pregnancy (present, suspected or planned) or positive pregnancy test. * previous enrollment in this trial. * patient's inability to fully cooperate with the study protocol.